Effectiveness Of 38% Silver Diamine Flouride In Arresting Caries With A Placebo Among Primary School Children In Hyderabad City: A Randomized Controlled Trial
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Caries arrest
研究概览
简要总结
| Untreated dental caries is a global pandemic. Due to limited financial resources, poor access to basic oral care, and the high cost of restorative treatment, children of low-income nations have their general health, social well-being, and education opportunities affected by untreated dental caries . |
- In this context, there is interest in simple treatments to halt progress of cavities (caries lesions) after tooth decay onset .
Arresting Caries Treatment (ACT) has been proposed to manage untreated dental caries in children of disadvantaged communities.
- Topical silver diamine fluoride is a clear liquid that is painted on the active lesion surface in milligram amounts and arrests the lesion.
- Cleared by the Food and Drug Administration in 2014 as a treatment for sensitive teeth and used off-label for the treatment of cavities in the United States since 2015,12 clinical trials outside the United States have documented caries arrest.
- Silver diamine fluoride (SDF) treatment has been identiï¬ed as a potential solution to address the dental public health issues of untreated dental caries and insufï¬cient access to care especially among disadvantaged children.
- The current study will assess the short term effectiveness of 38 percent SDF in arresting active caries lesions in children.
| · The Aim of this randomized controlled trial was to investigate and compare the short term effectiveness of topically applied 38% silver diamine fluoride with a placebo in arresting caries lesions in primary school children in Hyderabad city. |
Arandomized controlled trial will be carried out among 61 Primary school children inHyderabad city. The caries status of the children will be assessed using Nyvadcriteria (1999), wherein children with score 3 of Nvyad criteria will be included in the study. Thechildren will be randomly assigned to Active Group (n=31) and Control Group (n=30).The Active group will receive topicalapplication of 38% SDF and the control group receives topical application ofsterile water as ( placebo). Examination of caries lesions will be assessed at Baselineand after 21st day. On 21st day the number of lesions that are arrested will be evaluated based on the score 6 of Nyvad criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 11.00 Year(s)(—)
- 性别
- All
入选标准
- •Children having at least one untreated cavitated active caries lesion based on Nyvad criteria.[code :3 Enamel/dentin cavity easily visible with the naked eye; surface of cavity feels soft or leathery on gentle probing ] ï‚¢ Parents who gave written informed consent .
排除标准
- •Children not willing to participate in the study ï‚¢ Presence of any gingival or perioral ulceration or stomatitis or presence of a tooth abscess.
结局指标
主要结局
Caries arrest
时间窗: 30 days
次要结局
- Inhibits caries progression(30 Days)
